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How Long Must Records Related to the Manufacture of Medical Devices

Medical device manufacturing is a highly regulated field where product safety, quality, and compliance are critical. ISO 13485 is the internationally recognized standard for Quality Management Systems (QMS) specific to the medical device industry.

Medical device manufacturing is a highly regulated field where product safety, quality, and compliance are critical. ISO 13485 is the internationally recognized standard for Quality Management Systems (QMS) specific to the medical device industry. It outlines the requirements for consistent design, development, production, installation, and servicing of medical devices.

One important aspect of ISO 13485 is the requirement for record retention. These records serve as evidence of compliance, product history, and traceability, ensuring that manufacturers can respond to audits, customer inquiries, and regulatory investigations.

If you are looking for ISO 13485 Certification in Bangalore, understanding the record retention requirements is vital to building and maintaining a compliant QMS. Let’s break down what the standard says and what it means for your business.

Understanding ISO 13485 Record Retention Requirements

ISO 13485 requires organizations to retain records that demonstrate conformity to product requirements and the effectiveness of the QMS. Specifically, clause 4.2.5 of ISO 13485:2016 states:

Records shall be retained for at least the lifetime of the medical device as defined by the organization or as required by applicable regulatory requirements, but in no case less than two years from the date of product release.

In simpler terms:

  1. Minimum Period – At least two years from the date the device is released.
  2. Longer Period – If the device’s defined lifetime or applicable regulations specify a longer retention period, that requirement must be followed.

For example:

  • If a pacemaker has a life expectancy of 10 years, records should be retained for at least 10 years, or longer if required by law.
  • If a surgical instrument is designed for single use but your country’s regulations require a 5-year record retention, you must comply with the 5-year rule.

Why Record Retention Is Critical in Medical Device Manufacturing

Medical device records are not just paperwork—they are the proof that your organization consistently produces safe, compliant, and effective products.

Key reasons for maintaining these records include:

1. Regulatory Compliance

Many regulatory authorities, including the FDA (United States), EU MDR (Europe), and CDSCO (India), require manufacturers to keep manufacturing and design records for extended periods. ISO 13485 helps align your QMS with these requirements.

2. Product Traceability

If there is a recall, complaint, or adverse event report, retained records allow manufacturers to trace specific batches, materials, and processes used in the device’s production.

3. Legal Protection

Records can serve as evidence in legal proceedings, protecting the company against liability claims by demonstrating compliance and due diligence.

4. Audit Readiness

Certification bodies and regulatory agencies may request historical records during audits. Being prepared can prevent nonconformities and certification risks.

What Types of Records Must Be Retained?

ISO 13485 requires a variety of records related to manufacturing and quality control to be retained, including:

  • Design and development records (design inputs, outputs, changes, and verification results)
  • Device history records (manufacturing dates, batch/lot numbers, inspection results)
  • Device master records (specifications, manufacturing instructions, QC procedures)
  • Calibration and maintenance records for production equipment
  • Supplier and material traceability records
  • Nonconformity and corrective action records
  • Complaint handling and post-market surveillance data

Determining the Retention Period for Your Organization

While ISO 13485 provides the “at least two years” rule, the actual retention period may vary depending on:

  1. Regulatory Requirements – Countries have different legal obligations. For example:
    • EU MDR: Often requires retention for at least 10 years after the last device is placed on the market (15 years for implantable devices).
    • US FDA: Typically requires records for the expected life of the device, but not less than 2 years.
  2. Device Lifetime – Defined by your organization, based on product design and intended use.
  3. Risk Classification – Higher-risk devices may warrant longer record retention to ensure safety and traceability.
  4. Customer Contracts – Some contracts may specify longer retention requirements for quality records.

Best Practices for Record Retention under ISO 13485

For organizations seeking ISO 13485 Services in Bangalore, following these best practices ensures compliance:

  • Create a Record Retention Policy – Clearly define how long each type of record is kept and how it is archived.
  • Implement Secure Storage Systems – Whether digital or physical, ensure data integrity, security, and accessibility.
  • Regularly Review Retention Requirements – Regulatory updates may require policy changes.
  • Train Employees – Ensure staff understand the importance of accurate, complete, and timely recordkeeping.
  • Use Document Control Software – This simplifies storage, retrieval, and version control for quality records.

Role of ISO 13485 Consultants in Bangalore

Achieving and maintaining ISO 13485 compliance can be complex, especially when interpreting retention rules across different markets. ISO 13485 Consultants in Bangalore can help by:

  • Assessing your existing QMS against ISO 13485 and regulatory requirements
  • Developing a compliant record retention policy
  • Training employees on documentation and archiving procedures
  • Preparing you for certification and surveillance audits
  • Assisting in gap analysis to meet both ISO and country-specific requirements

Conclusion

Under ISO 13485, manufacturers must retain records related to the manufacture of medical devices for at least the lifetime of the device or as required by applicable regulations, but not less than two years from the product’s release date.

For companies aiming for ISO 13485 in Bangalore, proper record retention is not just a compliance necessity—it is a safeguard for product quality, regulatory approval, and business reputation. Partnering with professional ISO 13485 Services in Bangalore ensures your record management processes meet international standards and local regulations, helping you maintain trust and compliance in the competitive medical device industry.